Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia (Grecco)

Significant cognitive impairment (executive functions, memory, attention) is common in schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years, alternative non-pharmacological therapeutics have been developed in schizophrenia. These techniques called cognitive remediation specifically target cognitive deficits. The first cognitive remediation available for patients was designed to stimulate new learning, or relearning, of cognitive tasks, and thus to improve certain deficient domains. These procedures were efficient in improving cognition as measured by neurocognitive tests but their impact on functioning and daily life was weak. In a second time, compensatory remediation has been developed. Compensatory approaches seek to make improvements in the patient's functioning by avoiding areas of impairment and recruiting other intact cognitive domains or by creating a supportive external environment. In recent meta-analysis compensatory remediation has larger effect-size than classical cognitive remediation, with an impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of California) developed and tested a group-based, manualized, compensatory cognitive training intervention.

Compensatory cognitive training (CCT) is a low-tech, brief intervention and is easily transposable in community care. Our team translated this method into French. The investigators planned a cost -utility study between CCT and treatment as usual in schizophrenia patients with less than 10 years of evolution.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Other: Compensatory cognitive training; Other: Usual

Detailed Description

This study will take place over 3 years with a recruitment period of 18 months. After verification of the eligibility criteria and signature of the consent, the patients will be divided into 2 groups by randomization: the intervention group and the control group. The duration of participation of the subjects will be 12 months. Assessments are available in 4 steps (V1 at inclusion, V2 at 3 months, V3 at 6 months and V4 at 12 months). These visits include an assessment of the functioning of patients, symptomatology, quality of life, treatment and care received at all visits, occupational activity and cognitive assessment and social knowledge at V1 and V4.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Charles Perrens Hospital
  • Bron, France, 69678
    • Le Vinatier Hospital
  • Clermont-Ferrand, France, 63003
    • Gabriel-Montpied Univesity Hospital
  • Colombes, France, 92701
    • Louis Mourier Hospital
  • Créteil, France, 94000
    • Chenevier Hospital
  • Marseille, France, 13005
    • La Conception Hospital
  • Montpellier, France, 34295
    • Montpellier University Hospital
  • Saint-Égrève, France, 38521
    • Alpes Isère Hospital
  • Strasbourg, France, 67091
    • Strasbourg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnostic with schizophrénie
• Less than 10 years of the evolution of the disease

Exclusion Criteria:

• History of severe cranial trauma and / or neurological pathology with cognitive impairment
• Ongoing participation in another study for treatment of negative or cognitive symptoms
• Ongoing participation in a study on management in psychotherapy for cognitive disorders and negative symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Compensatory cognitive training	Other: Compensatory cognitive training; In addition to the usual care, method of compensatory cognitive remediation; Other Names: CCT
Placebo Comparator: usual treatment; usual treatment for shizophrenai	Other: Usual; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-utility questionnaire	Cost difference between the 2 group of patients	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functioning questionnaire	FROGS, Functional Remission of General Schizophrenia	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Assistance Publique - Hôpitaux de Paris; Assistance Publique Hopitaux De Marseille; University Hospital, Clermont-Ferrand; Hospital Center Alpes-Isère; Fondation FondaMental; University Hospital, Strasbourg; Hôpital Louis Mourier; Centre Hospitalier Charles Perrens, Bordeaux; Hôpitaux à Bron
• Investigators: Study Director: Delphine DC CAPDEVIELLE, MD-PhD, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimated): August 25, 2016

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cognitive remediation, cost-effectiveness analysis
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: RECHMPL15_0503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No